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Latch Instrument
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 260-101-655
by Bicon, LLC
Identity
- Trade Name
- Latch Instrument EUDAMEDLatch Reamer FDA UDI
- Generic Name
- Fixture/appliance dental drill bit, reusable FDA UDI
- Device Name
- Latch Instrument EUDAMEDDental Instrument EUDAMED5.5mm Latch Reamer FDA UDI
- Model / Reference
- 260-101-655 EUDAMEDFDA UDI
- Description
- 5.5mm Latch Reamer FDA UDI
Identifiers
- Catalog Number
- 260-101-655 FDA UDI
- Primary DI / UDI-DI
- 00813110024510 EUDAMEDFDA UDI
- Basic UDI-DI
- 081311002LIJ9 EUDAMEDB-00813110024510 EUDAMED
- Direct Marketing DI
- 00813110024510 EUDAMED
- FDA Product Code
- NDP FDA UDI
- EMDN Code
- L1508 REAMERS, REUSABLE EUDAMEDL159007 ODONTOSTOMATOLOGY BURS, REUSABLE EUDAMED
- GMDN Term
- Fixture/appliance dental drill bit, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3980 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Latch Instrument by Bicon, Llc — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 081311002LIJ9 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 081311002LIJ9 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Bicon, LLC
- EUDAMED SRN
- US-MF-000002782
- Authorised Representative
- Bicon Europe Ltd IE-AR-000002497
Sources (3)
- EUDAMED 5f22a957-4263-40ff-b02c-347da5de9e98 61 fields · synced Jul 8, 2026
- EUDAMED f2115f68-b45a-481a-bb47-91dbdc8391a4 61 fields · synced May 17, 2026
- FDA UDI 1d17b80e-c563-4b1e-9b8e-504afa0f17a1 35 fields · synced May 30, 2026